Establishment Licence Fees

Establishment licences are required for establishments that import or distribute any medical device. Licences are also required for manufacturers of Class I medical devices that do not sell through a licensed Canadian importer or distributor. Fees are charged for the initial licence, subsequent annual licences and the reinstatement of a licence. The fees are applied equally to foreign and domestic establishments. Some are exempt from establishment licence fees.

Fees for the Right to Sell Medical Devices

Health Canada monitors medical devices on the Canadian market through post-market surveillance and compliance and enforcement activities. There is an annual fee for the right to sell a Class II, III, IV medical device.